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A randomised controlled trial of pregnant women being monitored during labour with ST analysis monitoring and cardiotocography, compared to being monitored with cardiotocography alone, in order to reduce caesarean section whilst still having comparable outcomes for the baby.

In pregnant women with a singleton pregnancy at greater than 36 weeks gestation, having intrapartum monitoring, how does ST analysis (STan) intrapartum monitoring compare to conventional cardiotocography for selected neonatal and maternal outcomes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001308583
Acronym
Nil
Enrollment
1176
Registered
2015-11-30
Start date
2015-08-25
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a randomised controlled trial comparing a programme of monitoring unborn babies during labour using ST analysis (STan) of fetal ECG to intrapartum cardiotography. We aim to reduce our emergency caesarean section rate from 18% to 12% with improvement or clinical equivalence of neonatal outcomes, whilst maintaining maternal wellbeing and both maternal and caregiver satisfaction. The WCH is the first Australian centre to introduce STan fetal monitoring, as a part of a comprehensive educational package on fetal monitoring.

Interventions

Arm 1; Cardiotocographic monitoring only, using a external fetal doppler heart rate transducer strapped around the maternal waist or a metal scalp clip attached to the babies scalp, along with an external tocodynometer strapped to the mothers pregnant abdomen. These transducers and pressure monitors are attached to an electronic fetal monitor (CTG machine), which produces a graphic correlation of fetal heart rate to uterine activity. Trained medical and midwifery staff interpret these temporal c

Arm 1; Cardiotocographic monitoring only, using a external fetal doppler heart rate transducer strapped around the maternal waist or a metal scalp clip attached to the babies scalp, along with an external tocodynometer strapped to the mothers pregnant abdomen. These transducers and pressure monitors are attached to an electronic fetal monitor (CTG machine), which produces a graphic correlation of fetal heart rate to uterine activity. Trained medical and midwifery staff interpret these temporal correlations according to established guidelines. Arm 2: ST analysis (STan) fetal monitoring and cardiotocographic monitoring, using a specialised machine (Neovena STan monitor) that combines cardiotocographic monitoring (as above) with an electrocardiographic (ECG) recording of fetal cardiac activity, requiring a metal scalp clip attached to the unborn babies scalp. This monitoring is only commenced once the cervix is dilated enough and the membranes are ruptured, allowing the clip to be attached. A computerised analysis of the fetal ECG ST segment by the STan monitor provides additional information that is interpreted by guidelines developed by Neoventa by trained medical and midwifery staff. The randomisation is performed when the decision is made during labour by medical or midwifery staff that electronic fetal monitoring is necessary, and the monitoring is continued until delivery of the baby.

Sponsors

Chris Wilkinson
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

At least 18 years and capable of giving consent. Pregnancy expected to labour and deliver vaginally, singleton fetus, cephalic presentation, suitable for STan monitoring. Gestation must be greater than 36 completed weeks.

Exclusion criteria

Planned caesarean section; placenta praevia; low placenta; active vaginal infection; active genital herpes; HIV positive.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026